510(k) K153702 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
M3290B Philips IntelliVue Information Center iX
| Applicant | Philips Medical Systems, Andover MA, US |
| Decision | Substantially Equivalent, Jun 13, 2016 |
| Received | Dec 23, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K153702
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 11, 2026 | Philips North America Philips Patient Information Center iX
REF:866389 Open, Classified |
MHX | None listed |
| Sep 11, 2026 | Philips North America Philips PIC iX Essentials
REF:867093 Open, Classified |
MHX | None listed |
| Jan 22, 2026 | Philips North America Patient Information Center iX;
Software Version Number: 4.5.0 Open, Classified |
MHX | None listed |
| Oct 8, 2024 | Philips North America Patient Information Center iX, Product Code 866386, and Patient Information Center iX Expand, Product Code 866390, Software Revision 4.0.1 Open, Classified |
DSI | None listed |
| Sep 30, 2024 | Philips North America Llc DIVA 24 Inch Widescreen LCD Touch Display - Used with the Philips PIC iX system central
monitoring system.
Model: RGD2461AMI
Philips Part # 866126 Open, Classified |
MHX | None listed |
| May 15, 2024 | Philips North America Llc Patient Information Center iX and Patient Information Center iX Expand, Software Version 4.x. Open, Classified |
MHX | None listed |
| Apr 25, 2024 | Philips North America Llc Philips Patient Information Center (PIC) iX Uninterruptable Power Supply (UPS):
1. APC (Schneider Electric IT Corporation) 120V Uninterruptable Power Supply
Model: SCL500RM1U
2. APC (Schneider Elec Open, Classified |
MHX | None listed |
| Mar 27, 2024 | Philips North America Patient Information Center iX (PIC iX), Model Numbers 866389, 866390 (PIC iX Expand), and 866424 (PIC iX Hardware) running Software Version Number 4.X Open, Classified |
MHX | None listed |
| Jan 13, 2024 | Philips North America (1) Patient Information Center iX, Model No. 866389
(2) Patient Information Center iX Expand, Model No. 866390
(3) PIC iX Hardware, Model No. 866424 Open, Classified |
MHX | None listed |
| Jan 13, 2024 | Philips North America (1) CareEvent, Model No. 866435
(2) CareEvent Upgrade, Model no. 866436 Open, Classified |
MHX | None listed |
| Sep 19, 2023 | Philips North America Llc Patient Information Center iX with Software Version Number 4.x in the following:
(1) Patient Information Center iX Product Number: 866389;
(2) Patient Information Center iX Expand Product Number: 8 Open, Classified |
MHX | None listed |
| Apr 29, 2019 | Philips North America, LLC Philips Patient Information Center iX configured with a regional setting which uses a comma for a decimal separator:
866389 Patient Information Center iX B.01 (or later);
866390 Patient Information Ce Terminated |
MHX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.